This trial is active, not recruiting.

Condition asthmatic patients
Treatment azithromycin
Sponsor Universitaire Ziekenhuizen Leuven
Start date July 2011
End date June 2016
Trial size 17 participants
Trial identifier NCT01224977, Biomarker sputum airway study4


The main objectives of the study are:

1. To unravel the importance of molecular phenotyping in predicting the response to antimicrobial therapy with potential anti-inflammatory potency

The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:

1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.

2. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist.

3. These subgroups have different responses to anti-microbial therapy with potential anti-inflammatory potency (macrolides).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
azithromycin 500 mg 3/week for 3 months

Primary Outcomes

sputum cytokine mRNA
time frame: 3 months

Secondary Outcomes

responsiveness to the medication
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - severe asthmatics (GINA step 4 or step 5 (without anti-IgE)) Exclusion Criteria: - viral/fungal/bacterial infection +fever (<1 month) - asthma exacerbation (<3 months) - other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)

Additional Information

Official title Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.
Principal investigator Dominique MA Bullens, MD,PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.